MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF TAPPING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48814014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is in possession of the hardware.
Event or Problem Description
It was reported that the inferior screw was backing out and caused patient dysphagia; during the revision surgery, upon removal of the screw, the surgeon noted the locking wing of the plate had broken into several pieces.All pieces were removed from the field.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device is in the possession of the patient.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.It was reported that the initial surgery occurred over a year ago, exact date is unknown.The screws were prepared in the initial procedure as recommended by the surgical technique guide.Patient did not experience a fall, physical activity is unknown, and the patient had fully fused.Patient notes were not made available.Per surgical technique guide: "plate blockers should be in the unlocked position before attempting to prepare the screw hole.If self-tapping screws are selected, use a single barrel drill guide or all-in-one drill guide to guide the appropriate drill bit.If self-drilling screws are used, use either the punch awl with a sleeve or a drill bit and drill guide to center and direct the pathway of the screw.These devices are temporary stabilization devices until bone fusion has been achieved.After this period, the presence of the device is no longer strictly required and its removal can be planned.Removal may also be necessary as a result of the above mentioned adverse effects." potential root caused based on the risk file: improper plate sizing or contouring; excessive post-op activity by patient (not recommended by surgeon); patient does not follow surgeon instructions; patient over exerts.Device is in the possession of the patient.
Event or Problem Description
It was reported that the inferior screw was backing out and caused patient dysphagia; during the revision surgery, upon removal of the screw, the surgeon noted the locking wing of the plate had broken into several pieces.All pieces were removed from the field.

• Brand Name: AVIATOR VARIABLE SELF TAPPING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8629254
• Report Number: 0009617544-2019-00073
• Device Sequence Number: 1857776
• Product Code: KWQ
• UDI-Device Identifier: 07613252152507
• UDI-Public: 07613252152507
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48814014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention